Recalls / Class III
Class IIID-1142-2015
Product
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)
- Affected lot / code info
- Lot #: 2625094, Exp 06/2016
Why it was recalled
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Recalling firm
- Firm
- Ohm Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1385 Livingston Ave, North Brunswick, New Jersey 08902-1829
Distribution
- Quantity
- 2592 Blister Packs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-05-04
- FDA classified
- 2015-06-18
- Posted by FDA
- 2015-06-24
- Terminated
- 2016-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1142-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.